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Although there are a wide variety of pharmacological, physiological, and biochemical endpoints that could be used as a biomarker, not all of them are suitable for application in a drug discovery and development program. The role of a biomarker and translational medicine, in general, is to increase the efficiency of the identification of new therapeutic entities. As a result, biomarkers that are difficult to measure, associated with expensive or long experiments, or are difficult to reproduce are generally not suitable for a drug discovery and development program. Biomarkers of this type may provide important scientific information that could be useful to society as a whole, but their added cost would create an additional drag on a program rather than increase its efficiency.
Ideally, biomarkers suitable for drug discovery and development programs need to be easily measured, time-efficient, quantitative, objective, and highly reproducible. Importantly, the results obtained from experiments using a biomarker should be useful for predicting results in the next stage of experimentation. In other words, a biomarker should be translational in nature. Clinical relevance and reliability across a heterogeneous patient population are also important hallmarks of an ideal biomarker.
Biomarkers have been developed using complex gene and proteins expression systems, biochemical tools to measure blood concentration of key molecules, and advanced imaging techniques such as computed tomography scanning, positron emission tomography techniques, and single-photon emission computed tomography imaging. However, not all biomarkers are complex. Blood pressure, heart rate, and even body temperature measurements would also be considered biomarkers based on the definitions. These and other simple biomarkers have been available for a very long time. However, the broad-based application of biomarkers within the context of translational medicine to increase the efficiency of drug discovery and development dramatically increased at the beginning of the twenty-first century. Their primary purpose is to provide the scientists with the data necessary to make a more informed decision about whether or not a candidate compound is worthy of further evaluation by providing data that can be used to predict performance in future studies. In theory, if scientists are better equipped to identify compounds with the desired properties using predictive assays and methods, then the compounds that move forward would be more likely to eventually reach the market. Similarly, the ability to predict which compounds possess undesirable properties would eliminate efficacious compounds that would fail in clinical trials as a result of poor safety outcomes. In both cases, fewer compounds reach more advanced and more expensive assays, reducing the overall cost of the process.
In considering the use of biomarkers, it is important to understand that their use is not limited to clinical trials. Significant cost and time savings can be achieved by the judicious use of biomarkers in the discovery/preclinical stage of the drug development process. Consider, for example, a program that has identified a set of 10 compounds with in vitro biochemical properties that suggest efficacy and selectivity for the desired biochemical target. In vivo pharmacokinetic (PK) studies must be completed before launching in vivo efficacy studies. While it is certainly possible to run in vivo PK studies on all 10 compounds, there are several biomarkers assays available that can be used to predict certain aspects of in vivo PK. In vitro microsomal stability studies and permeability studies, for example, can be used to identify compounds that are less likely to have the in vivo PK properties necessary to support efficacy. Compounds that are rapidly metabolized by microsomes are likely to be highly metabolized in vivo, while compounds that perform poorly in vitro permeability assays are likely to have limited bioavailability. Although assay of this type is not a perfect predictor of in vivo PK, they can be very effective in prioritizing compounds based on their likelihood of having the desired PK properties. Ideally, this translates into fewer compounds moving into in vivo PK models, saving both time and money.
Fig 1. Different utilities of biomarkers. (Lyngbakken, 2019)
Creative Biolabs provides a comprehensive suite of customized Drug Discovery services in a timely and cost-effective manner to satisfy your specific needs. Whether you have any questions about our services or biomarkers, please contact us and we will provide you with a detailed explanation.
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